510(k) Report

FDA applicant

Blackford Analysis, Ltd.

Edinburgh, Midlothian, GB1 decision2015–20150 recalls

FDA records 1 decision for Blackford Analysis, Ltd. (Edinburgh, Midlothian, GB) in 2015: 1 510(k) clearance. All are in product code LLZ (System, Image Processing, Radiological). No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, radiology panel, where it files most

How often FDA has decided Blackford Analysis, Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2015

2015: 1
2015high 1 (2015) · low 0 (2016)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2015.

FIG. 1 — Blackford Analysis, Ltd. by year, 2015–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • LLZSystem, Image Processing, Radiological1decision

Who builds on its devices?

Later devices cite its devices 1 time; 0 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K142337Blackford Analysis Registration Product FamilyBlackford Analysis, Ltd. · 20151cites it

What has FDA decided for it lately?

  • K142337Blackford Analysis Registration Product FamilyBlackford Analysis, Ltd. · 2015

The one decision as Blackford Analysis, Ltd. →